QA Laboratory Compliance Specialist III

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a QA Laboratory Compliance Specialist III as part of the Quality team based in Raritan, NJ . Role Overview The QA Lab Compliance (QALC) specialist III role is an exempt level position with responsibilities for providing quality and compliance oversight over all functions of the Quality Control Laboratories responsible for testing Advanced therapy products. QALC will work in a collaborative team setting with quality counterparts that include all Quality Control Departments including QC Release, QC IPL, QC Micro, QC Lab Services and QC Investigations. Key Responsibilities Work in close collaboration with QC functional areas to provide QA oversight. Attend 1/1 meetings with QA supervisors. Train and coach Level I/II QALC when performing newer day-to-day activities. Oversight for QC laboratories to ensure quality, compliance, and adherence to global standards as well as regulatory requirements. Support Level I/II QALC by overseeing the completion of spot-checks for QC Laboratories to ensure compliance wit